Clinical trial · Interventional
To Observe the Dual-target Chimeric Antigen Receptor T Cells in the Treatment of B Cell Hematologic Tumors
To Observe the Long-term Efficacy and Safety of Dual-target Chimeric Antigen Receptor T Cells in the Treatment of Refractory Relapsed B Cell Hematologic Tumors
NCT05388695CI-TRIAL-00091144recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To observe the long-term efficacy and safety of dual-target chimeric antigen receptor T cells in the treatment of refractory relapsed B cell hematologic tumors (at least 2 years).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| 19 and 20+ B Cell Hematologic Tumors | — | UNRESOLVED | — |
| 19 and 22+ B Cell Hematologic Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous CD19/CD22/CD20 Chimeric Antigen Receptor T-cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 19+22 CART and 19+20 CART
- description
- Eligible patients will be treated with 19+22 CAR-T and 19+20 CAR-T.
- interventionNames
- Biological: Autologous CD19/CD22/CD20 Chimeric Antigen Receptor T-cells
Primary outcomes (1)
- measure
- Efficacy: Remission Rate
- timeFrame
- Up to 3 months
- description
- Remission Rate includes complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Refractory and relapsed B-cell tumor determined by clinical diagnosis, B cell tumors include the following three categories: B cell acute lymphocyte leucocyte; Inert B cell lymphoma (CLL、 FL、 MZL); Aggressive B-cell lymphoma (DLBCL、 BL、 MCL); 2. CD19 positive and CD20 positive or CD22 positive were detected by immunohistochemistry or flow cytometry; 3.18 years old≤age≤70 years old; 4.Estimated survival time\>3 months; 5.ECOG Scores: 0\~2; 6.There should be at least one measurable tumor foci according to RECIST Version 1.1; 7.The functions of vital organs must meet the following conditions: EF\>50%, and no obvious abnormality of electrocardiogram; SpO2≥92%; Cr≤1.5ULN; ALTand AST≤5ULN, TBil≤3ULN; 8.Subjects planning to become pregnant must agree to use contraception prior to enrolling in the study and after six months of study duration; inform the investigator immediately if the subject becomes pregnant or suspects pregnancy; 9.The subject or guardian understands and signs the informed consent. Exclusion Criteria: 1. With other diseases that are not effectively controlled, including, but not limited to, persistent or poorly controlled infections symptomatic congestive heart failure unstable angina arrhythmia poorly controlled pulmonary disease or psychiatric disease; 2. Presence of other malignant tumors; 3. There are severe infections that cannot be effectively controlled; 4. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, peripheral blood hepatitis B virus (HBV)DNA higher than the detection limit should be excluded; If hepatitis C virus (HCV) antibody positive, peripheral blood HCV RNA positive need to exclude; Cytomegalovirus (CMV)DNA positive; Epstein-barr virus DNA positive in peripheral blood; 5. Known positive serology for human immunodeficiency virus (HIV) or syphilis; 6. A history of severe allergies to biological products (including antibiotics); 7. Patients with relapses after allogeneic hematopoietic stem cell transplantation with grade 3-4 acute graft-versus-host disease (GvHD); 8. Female patients who are under pregnancy and/or lactation; 9. Active autoimmune disease requiring systemic immunosuppressive therapy; 10. Conditions that the investigator believes may increase the risk to the subject or interfere with the results of the study.
References
Publications (1)
- DERIVEDHe S, Peng J, Yang X, Meng F, Huang L, Huang L, Tian W, Gao Z, Zhao J, Wang Z, Wei J. Peripheral Blood Smears Distinguish Infective Fever after CAR-T Therapy. Front Biosci (Landmark Ed). 2023 Nov 24;28(11):299. doi: 10.31083/j.fbl2811299. PMID 38062808